Systems and methods for prosthetic suspension system

ABSTRACT

A prosthetic device includes an inner socket assembly including an upper interface member having a generally cylindrical outer periphery, the outer periphery defining a diameter and a length, the diameter being substantially greater than the length, and an outer socket assembly including a lower interface member having a recess correspondingly-shaped to the outer periphery of the upper interface member. At least a portion of the upper interface member is received within the recess of the lower interface member to secure the inner socket assembly to the outer socket assembly.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is a continuation of and claims priority to U.S. patentapplication Ser. No. 13/754,553, entitled “SYSTEMS AND METHODS FORPROSTHETIC SUSPENSION SYSTEM,” filed on Jan. 30, 2013, which claims thebenefit of U.S. Provisional Application No. 61/593,225, filed Jan. 31,2012, both of which are incorporated by reference herein in theirentireties and for all purposes.

BACKGROUND

The present disclosure relates generally to the field of prostheticdevices, and more specifically, to a suspension system usable withprosthetic devices such as lower limb prosthetics.

There are many challenges associated with providing an effective meansof supporting, for example, a lower residual portion of a leg, within aprosthetic device. As such, various embodiments disclosed herein relatedto improved systems and methods of prosthetic device suspension systems.

SUMMARY

One embodiment relates to a prosthetic device comprising an inner socketassembly comprising an upper interface having a generally cylindricalouter periphery, the outer periphery having a diameter substantiallygreater than a length; an outer socket assembly comprising a lowerinterface having a recess correspondingly-shaped to the outer peripheryof the upper interface; wherein at least a portion of the upperinterface is received within the recess of the lower interface to securethe inner socket assembly to the outer socket assembly.

Another embodiment relates to a prosthetic device, comprising an innersocket assembly having a lower portion defining a disc-shaped adapter;an outer socket assembly comprising a receptacle configured toreleasably engage the inner socket assembly; wherein the interface ofthe disc-shaped adapter and the receptacle acts to secure the innersocket assembly to the outer socket assembly.

Another embodiment relates to a prosthetic device, comprising an innersocket assembly configured to receive a portion of a residual limb of auser; an outer socket assembly configured to receive at least a portionof the inner socket assembly; and an interface mechanism configured toreleasably secure the inner socket assembly to the outer socket assemblyduring use of the prosthetic device by a user, the interface mechanismcomprising a generally cylindrical member provided on one of the innersocket assembly and the outer socket assembly; and a receptacle providedon the other of the inner socket assembly and the outer socket assemblyand having a recess configured to releasably secure the outer socketassembly to the inner socket assembly in a non-rotational manner.

BRIEF DESCRIPTION

The present disclosure will become more fully understood from thefollowing detailed description, taken in conjunction with theaccompanying drawings, wherein like reference numerals refer to likeelements.

FIG. 1 is a side view of a prosthetic device secured to a residual limbaccording to an exemplary embodiment.

FIG. 2 is an exploded view of a portion of a prosthetic device accordingto an exemplary embodiment.

FIG. 3 is an exploded view of a portion of a prosthetic device accordingto another exemplary embodiment.

FIG. 4 is an exploded view of a portion of a prosthetic device accordingto another exemplary embodiment.

FIG. 5 is an exploded view of a portion of a prosthetic device accordingto another exemplary embodiment.

FIG. 6 is an exploded view of a portion of a prosthetic device accordingto another exemplary embodiment.

FIG. 7 is a cross-sectional view of an adapter usable with a prostheticdevice according to an exemplary embodiment.

FIG. 8 is a perspective view of an adapter usable with a prostheticdevice according to an exemplary embodiment.

FIG. 9 is an exploded view of a prosthetic device according to anotherexemplary embodiment.

FIG. 10 is a cross-section view of a portion of the prosthetic device ofFIG. 9 according to an exemplary embodiment.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Referring generally to the FIGURES, various embodiments of prostheticdevices are shown according to exemplary embodiments. Though variousembodiments herein are described in the context of an artificial leg, itis contemplated that the present disclosure is equally applicable toother contexts in which a device is connected to a user's body. Forexample, the device could be an artificial arm, an orthotic component,or another prosthetic/orthotic product that uses similar methods toconnect to a user. The connection method need not be a fullyencompassing socket like a prosthesis. Further, a vacuum could assist aconnection device or may be used as a stabilizer in connection withvarious connection methods.

A conventional lower leg prosthetic device may include an inner liner,or inner socket, that receives a residual limb and is coupled to a morerigid outer frame, or outer socket. To couple the inner liner to theframe, relatively long, narrow pins may be used in conjunction with alocking mechanism such as a ratchet, clutch, or strangulation mechanism.However, these types of pin connection mechanisms often have drawbacks,such as vertical movement of the pin, wobbling of the pin, wear of thelocking mechanism, or improper operation of the pin/locking mechanismdue to infiltration of dirt, debris, etc.

Furthermore, relatively long, narrow pins may have a small point ofcontact between the inner liner and the frame, which may result inadditional problems related to the mechanical suspension of the innersocket within the frame, including movement (e.g., wobbling, etc.)between the inner socket and the frame, undesirable transfer of pressureto the distal end of the residual limb (e.g., due to vertical movementof the pin during the heel strike motion, resulting in “tightening” ofpin connection), and/or undesirable “pistoning” from slack in the pinlocking mechanism permitting vertical movement between inner liner andrigid frame. Pistoning may in turn lead to “milking” of the residuallimb (e.g., the repetitive application and release of downward forcesand/or pressures on the residual limb). Furthermore, during the “swingphase” of a patient's gate, most or all of the pressure relating toretaining the prosthesis on the residual limb may be concentrated on thepin.

Various embodiments disclosed herein may address one or more of theseconcerns by providing improved systems and methods of suspension forprosthetic devices. Some embodiments may be usable in a “retrofit”application to modify existing pin locking mechanism arrangements. Otherembodiments may be usable in new devices to provide an improvedsuspension system for patients.

Referring now to FIGS. 1-2, a prosthetic device 10 is shown according toan exemplary embodiment. Device 10 includes a socket assembly 12, apylon 14, an artificial foot 16, and a control system 18. Device 10 isintended to restore functionality to patients having lost limbs such aslegs, arms, and the like. Generally, socket assembly 12 receives aportion of a residual limb of a user. Pylon 14 is a mechanical structurethat provides a mechanical support and interface between socket assembly12 and artificial foot 16. Artificial foot 16 may be designed toreplicate a real foot (or, similarly, a hand, etc., depending on theparticular application). As described in greater detail below, controlsystem 18 controls an amount of vacuum applied to the socket assembly12, where the vacuum provides a negative pressure to maintain theresidual limb securely in place within the socket assembly. Based onvarious factors, control system 18 may vary the vacuum applied to socketassembly 12 to optimize the performance of device 10 for users.

Referring further to FIGS. 1-2, according to one embodiment, a residuallimb of a user is received within an inner liner or socket 20 (e.g., aflexible or semi-rigid liner or socket). Inner liner 20 may beconfigured to fit around the residual limb and into an outer socket orframe 22 (e.g., a rigid frame or socket, etc.). In some embodiments,inner liner 20 may be formed of a gel or silicone material, while othermaterials may be used according to various other alternativeembodiments. The particular size and/or shape of inner liner 20 may varydepending on the user and the particular device 10 being utilized.According to one embodiment, inner liner 20 is sized to avoid discomfortto the user and/or improper fit of device 10.

According to an exemplary embodiment, frame 22 may be provided with asize and shape customized to a particular user such that a substantialportion of a residual limb may be received within the interior of frame22. An additional liner may be applied to the residual limb prior toinsertion into inner liner 20. As shown in FIG. 2, a cavity 28 mayremain after insertion of the residual limb into inner liner 20 andprior to application of a vacuum to socket assembly 12. A desired vacuummay be applied to cavity 28 to provide a proper fit between the residuallimb and inner liner.

According to an exemplary embodiment, a sealing sleeve 24 (see FIG. 1)may be configured to form an airtight seal between the residual limb andinner liner 20. For example, sealing sleeve 24 may in some embodimentsbe a non-foamed, nonporous polyurethane suspension sleeve that rollsover and covers a portion of inner liner 20 and a portion of theresidual limb. The inner surface of sealing sleeve 24 may provide a sealagainst the skin on the user's thigh and the outer surface of innerliner 20 to provide an airtight seal for the vacuum. Sealing sleeve 24may be applied over the outer surface of inner liner 20 and rolled uponto the thigh portion of the residual limb to provide a vacuum seal andenable device 10 to achieve appropriate vacuum (measured in, e.g.,inches of mercury) and prosthetic suspension.

According to an exemplary embodiment, pylon 14 is attached to socketassembly 12 at an upper portion 30 of pylon 14. Lower portion 32 ofpylon 14 may be coupled to and/or form a part of artificial foot 16. Anysuitable coupling means may be used to couple pylon 14 to artificialfoot 16. According to an exemplary embodiment, artificial foot 16 isconfigured to substantially replicate an actual human foot in shape,size, and/or range of motion. As indicated above, while the embodimentsdisclosed herein generally refer to a lower limb prosthetic device usedin connection with an artificial foot, the teachings herein extend toother applications, including upper limb prosthetics and other devicesthat would benefit from the features disclosed herein. Artificial foot16 may be made any suitable material, and the shape, size, and othercharacteristics of artificial foot 16 may be varied from those describedherein to suit a particular user and/or application.

According to an exemplary embodiment, pylon 14 is fixedly secured toframe 22, e.g., via a pyramid/pylon adapter 31. Inner liner 20 may becoupled to frame 22 via an interface or coupling mechanism 40. Accordingto various exemplary embodiments, coupling mechanism 40 provides amechanical coupling or suspension system between liner 20 and frame22/pylon 14. As discussed in greater detail herein, mechanism 41 mayprovide various benefits relative to more traditional coupling systemshaving relatively long, narrow pin locking mechanisms.

Referring to FIG. 2, a portion of a prosthetic device such as device 10is shown according to an exemplary embodiment and includes couplingmechanism 40. As shown in FIG. 2, mechanism 40 includes an adapter 42(e.g., a generally cylindrical member, a disc-shaped member, etc.) and areceptacle 44 (e.g., a member having a generally cylindrical recess,etc.), and acts to couple inner liner 20 to frame 22 via adapter 42 andreceptacle 44. For example, in one embodiment, inner liner 20 mayinclude a threaded insert 46. Threaded insert 46 may be usable toreceive a threaded pin to couple inner liner 20 to frame 22 in aconventional manner. Adapter 42 may have a central threaded portion 49(see FIG. 8) that may be threadingly received by threaded insert 46 toform an upper interface or coupling portion of coupling mechanism 40.Adapter 42 and/or receptacle 44 may be made of any suitable metal,plastic, or composite material.

Receptacle 44 may be secured to frame 22 and pylon 14 using, forexample, one or more fasteners 51. As shown in FIG. 2, one or morefasteners may extend upward through pylon 31 and frame 22 and intoreceptacle 44. Receptacle 44 may extend upward from the inner bottom offrame 22 and be configured to engage adapter 42. For example, as shownin FIG. 2, receptacle 44 may have a generally cylindrical outerperiphery and a recess 47 formed therein (e.g., by a generally circularsidewall). In one embodiment, recess 47 is correspondingly shaped toadapter 42 such that at least a portion of adapter 42 is configured tobe releasably received by recess 47. For example, a user may insert aportion of a residual limb inside of inner liner 20, with adapter 42attached to a bottom portion thereof. In order to secure inner liner 20to frame 22 having receptacle 44 attached thereto, the user may insertthe liner/adapter into the interior of the frame until adapter 42engages receptacle 44 to securely fasten inner liner 20 to frame 22.

Adapter 42 may be releasably coupled to receptacle 44 using a variety ofsuitable methods. For example, in some embodiments, the geometry ofadapter 42 and receptacle 44 may be such that a “snap-fit” engagement(e.g., by way of indents/detents, interfering structural portions, etc.)between the outer periphery (or portions thereof) of adapter 42 andrecess 47. In other embodiments, a variety of latches, spring-loadedretention members, and other securement devices may be utilized. Forexample, one or both of adapter 42 and/or receptacle 44 may include aspring-loaded or biased projection intended to engage a correspondingsurface or recess upon mating of the adapter and receptacle.

According to an exemplary embodiment, adapter 42 comprises a generallycylindrical outer surface, at least a portion of which is received byrecess 47. For example, adapter 42 may have a diameter that issubstantially greater than its length (e.g., measured along alongitudinal axis of the prosthetic device). For example, the diameterof adapter 42 (e.g. the engagement portion of adapter 42 that interfereswith receptacle 44) may be approximately 2, 3, or 4 times its length.According to other embodiments, the diameter of adapter 42 may be largeror smaller relative to the length of adapter 42. Providing an adapter 42having an increased diameter, and therefore a relatively large bottomsurface area, acts to increase the surface area over which forces may betransmitted between frame 22 and inner liner 20 (and potentially, theresidual limb of a user). Furthermore, an increase in the surface areaof the interface between frame 22 and inner liner 20 may provide a morestable connection and avoid undesirable movement between frame 22 andinner liner 20 during use of prosthetic device 10 by a user.

As shown in FIG. 2, coupling mechanism 40 may be usable to retrofit moretraditional pin locking mechanisms that utilize a threaded insert ininner liner 20. Furthermore, as shown in FIG. 3, the relative positionsof adapter 42 and receptacle 44 may be reversed, such that receptacle 44may be attached to inner liner 20 and adapter 42 may be attached toframe 22. Further yet, rather than accommodating liners and framesoriginally intended to be used with a pin locking mechanism in aretrofit application, coupling mechanism 40 may be integrated into innerliner 20 and/or frame 22, as discussed in greater detail with responseto FIGS. 4-5.

Referring now to FIG. 4, inner liner 20 is shown to have receptacle 44integrated therewith. In one embodiment, receptacle 44 may be molded orcast with the bottom portion of inner liner 20, such that threadedinsert 46 (see, e.g., FIG. 2) is not required. As with the embodimentsof FIGS. 2-3, the relative positions of adapter 42 and receptacle 44 maybe reversed, such that adapter 42 may in some embodiments be integratedwith inner liner 20. Similarly, adapter 42 or receptacle 44 may beintegrated into frame 22 in yet further embodiments.

According to some embodiments, receptacle 44 substantially surrounds atleast a portion of the peripheral sidewalls (e.g., cylindricalsidewalls) of adapter 22. In other embodiments, as shown for example inFIG. 5, adapter 42 may include an annular slot, or recess 48, such thatthe outer walls of receptacle 44 that form recess 47 are received withinslots 48, thus forming interlocking walls/recesses between adapter 42and receptacle 44. The configuration of FIG. 5 may provide addedstability for users by providing another means for preventing relativemotion between inner liner 20 and frame 22.

In some embodiments, coupling mechanism 40 includes structural features(e.g., a keyed portion, non-circular geometries, indents/detents, etc.)intended to prevent relative rotational motion between adapter 42 andreceptacle 44, and in turn, inner liner 20 and frame 22. Any suitableanti-rotational structural features may be used according to variousalternative embodiments.

According to any of the embodiments discussed herein, a vacuum may beprovided to secure the residual limb within inner liner 20. A vacuumpump 58 (see FIG. 7) may be connected to socket assembly 12 via a fluidconnection that provides fluid communication between the pump and cavity28 of socket assembly 12. Any suitable pump may be utilized (e.g., adiaphragm pump driven by a DC motor, etc.). Operation of pump 58 createsa partial vacuum in cavity 28 that in turn secures the residual limb tosocket assembly 12. Vacuum pump 58 may be coupled to pylon 14, orlocated at other locations on device 10. For example, according to oneembodiment, pump 58 may be provided within or adjacent either adapter 42and/or receptacle 44.

Referring to FIG. 6, receptacle 44 is shown to include an upstandingvalve 52 configured to provide fluid communication with cavity 28 via apassageway 50. Receptacle 44 may further provide a fluid communicationbetween valve 52 and a port 54 (e.g., a barbed port, etc.) whichcommunicates with a vacuum source (e.g., a vacuum pump coupled to orintegrated into device 10). Alternatively, referring to FIG. 7, a vacuumpump and/or associated controlling electronics (e.g., an electroniccontroller to control operation of the vacuum pump) may be disposedwithin or at least partially within adapter 42 (or similarly, receptacle44). An o-ring 56 may be provided to ensure an air-tight seal betweenadapter 42 and surrounding components (e.g., inner liner 22, etc.) and avacuum port may connect a pump 58 with, for example, cavity 28, by wayof passageway 50. Other configurations of vacuum pumps, ports, andassociated passageways may be used according to various alternativeembodiments.

Referring to FIGS. 9-10, in some embodiments a check valve may be usedto control the pressure within the inner sleeve. For example, a valveassembly may be integrated into adapter 42 as shown in FIG. 9. Accordingto one embodiment, the valve assembly is a check valve assembly andincludes a liner lock 60, a sealing member such as an o-ring, a checkvalve retainer 64, and a check valve 66. Liner lock 60 extends throughan additional liner 62 (e.g., a polyethylene liner) and inner liner 20and threadingly engages adapter 42. Check valve 66 is configured topermit air to flow out of, but not into, the prosthetic device, and topermit exhausted air to exit via a channel and port 70. As a userinserts inner liner 20 into frame 22 (not shown in FIG. 10), air may beexhausted through the valve assembly and out from adapter 20, generatinga partial vacuum within the socket assembly. This configuration maygenerate vacuum during initial insertion of inner liner 20 into frame22, and during use of the prosthetic device (e.g., during walking), totake advantage of a user's weight in generating vacuum within theprosthetic device. In some embodiments, the valve assembly may be usedin conjunction with a separate vacuum system to provide additionalvacuum to the prosthetic device.

It is important to note that the construction and arrangement of theelements of the prosthetic device as shown in the exemplary embodimentsare illustrative only. Although only a few embodiments have beendescribed in detail in this disclosure, those skilled in the art whoreview this disclosure will readily appreciate that many modificationsare possible (e.g., variations in sizes, dimensions, structures, shapesand proportions of the various elements, values of parameters, mountingarrangements, materials, colors, orientations, etc.) without materiallydeparting from the novel teachings and advantages of the subject matterrecited in the embodiments. For example, for purposes of thisdisclosure, the term “coupled” shall mean the joining of two membersdirectly or indirectly to one another. Such joining may be stationary innature or movable in nature. Such joining may be achieved with the twomembers or the two members and any additional intermediate members beingintegrally formed as a single unitary body with one another or with thetwo members or the two members and any additional intermediate memberbeing attached to one another. Such joining may be permanent in natureor alternatively may be removable or releasable in nature. Such joiningmay also relate to mechanical, fluid, or electrical relationship betweenthe two components. Accordingly, all such modifications are intended tobe included within the scope of the present disclosure as defined in theappended claims. The order or sequence of any process or method stepsmay be varied or re-sequenced according to alternative embodiments.Other substitutions, modifications, changes, and/or omissions may bemade in the design, operating conditions, and arrangement of theexemplary embodiments without departing from the spirit of the presentdisclosure.

What is claimed is:
 1. A prosthetic device comprising: an outer socket;an inner liner configured to fit around a residual limb of a user andconfigured to fit into the outer socket, the inner liner including anupper interface member integrated with the inner liner; a lowerinterface member coupled to an inner surface of the outer socket andconfigured to interface with the upper interface member to releasablysecure the inner liner to the outer socket; and a pylon coupled to anouter surface of the outer socket, wherein the outer surface is oppositethe inner surface.
 2. The prosthetic device of claim 1, wherein theupper interface member is molded or cast with a bottom portion of theinner liner
 3. The prosthetic device of claim 1, wherein the pylon iscoupled to the outer socket by one or more fasteners that extend throughthe pylon, through the outer socket, and into the lower interfacemember.
 4. The prosthetic device of claim 1, wherein one of the upperinterface member or the lower interface member comprises a generallycylindrical outer surface having a diameter that is substantiallygreater than its length as measured along a longitudinal axis of theprosthetic device.
 5. The prosthetic device of claim 4, wherein theother of the upper interface member or the lower interface membercomprises a receptacle having a generally cylindrical recess, thegenerally cylindrical recess sized and shaped to receive at least aportion of the generally cylindrical outer surface.
 6. The prostheticdevice of claim 5, wherein the generally cylindrical recess is formed bya raised annular wall of the receptacle, and wherein the generallycylindrical outer surface includes an annular slot configured to receivethe raised annular wall of the receptacle in an interlocking manner. 7.The device of claim 1, further comprising a vacuum pump configured togenerate a vacuum within the inner socket assembly, wherein the vacuumpump is in fluid communication with an interior of the inner socketassembly via at least one of the upper interface member and the lowerinterface member.
 8. The device of claim 1, wherein the upper interfacemember is rotationally fixed relative to the lower interface.
 9. Aprosthetic device comprising: a socket assembly having: a rigid outersocket, an inner liner configured to fit around a residual limb of auser and configured to fit into the outer socket, the inner linerincluding an upper interface member integrated with the inner liner, anda lower interface member coupled to an inner surface of the outer socketand configured to interface with the upper interface member toreleasably secure the inner liner to the outer socket; a pylon coupledto the socket assembly at an upper portion of the pylon; and a vacuumpump configured to generate a vacuum within the inner socket assembly.10. The prosthetic device of claim 9, wherein the upper interface memberis molded or cast with a bottom portion of the inner liner
 11. Theprosthetic device of claim 9, wherein the pylon is coupled to the upperportion of the socket assembly one or more fasteners that extend throughthe pylon, through the outer socket, and into the lower interfacemember.
 12. The prosthetic device of claim 9, wherein one of the upperinterface member or the lower interface member comprises a generallycylindrical outer surface having a diameter that is substantiallygreater than its length as measured along a longitudinal axis of theprosthetic device.
 13. The prosthetic device of claim 12, wherein theother of the upper interface member or the lower interface membercomprises a receptacle having a generally cylindrical recess, thegenerally cylindrical recess sized and shaped to receive at least aportion of the generally cylindrical outer surface.
 14. The prostheticdevice of claim 13, wherein the generally cylindrical recess is formedby a raised annular wall of the receptacle, and wherein the generallycylindrical outer surface includes an annular slot configured to receivethe raised annular wall of the receptacle in an interlocking manner. 15.The prosthetic device of claim 9, wherein the vacuum pump is in fluidcommunication with an interior of the inner socket assembly via at leastone of the upper interface member and the lower interface member
 16. Aprosthetic device, comprising: an inner socket assembly configured toreceive a portion of a residual limb of a user; an outer socket assemblyconfigured to receive at least a portion of the inner socket assembly;and an interface mechanism configured to releasably secure the innersocket assembly to the outer socket assembly during use of theprosthetic device by a user, the interface mechanism comprising: agenerally cylindrical member having a diameter that is substantiallygreater than its length as measured along a longitudinal axis of theprosthetic device, and a receptacle having a generally cylindricalrecess, the generally cylindrical recess sized and shaped to receive atleast a portion of the generally cylindrical member, wherein one of thegenerally cylindrical member or the receptacle is integrated with theinner socket assembly.
 17. The device of claim 16, wherein the interfacemechanism prevents relative rotational movement of the inner socketassembly and the outer socket assembly.
 18. The device of claim 16,further comprising a valve assembly disposed within the interfacemechanism.
 19. The device of claim 18, wherein the valve assemblycomprises a check valve configured to permit air to exhaust from acavity defined between the residual limb and the inner liner.
 20. Thedevice of claim 16, wherein the one of the generally cylindrical memberor the receptacle that is integrated with the inner socket assembly ismolded or cast with a bottom portion of the inner socket assembly.